China: EXCEL PharmaStudies Inc.

Excel is a full-service provider of registration, clinical research, biometrics, and training and consultation services. Excel is the leading CRO in China. With more than 350 staff members, operations in 20 cities in the Asia Pacific region, and experience working with over 120 of the world’s leading pharmaceutical and biotech companies, Excel has the resources, connections, and expertise needed to help you with your drug development needs in Asia.

We have succeeded in obtaining over 260 registration approvals/import licenses from the State Food and Drug Administration (SFDA) in China, and that number continues to grow. We initiate 70-80 new Clinical Trial Approvals (CTAs) or license applications per year. Our ability to provide the decisive technical solutions that deliver product licenses is the reason why nearly all of the world’s top 20 pharmas have chosen Excel as their registration services provider in China.

Services provided by Excel:

• Regulatory Affairs in China – Registration for pharmaceuticals, medical devices and IVDs, and healthcare and cosmetics products
• Clinical Studies in China – Study design, study management and site management, study monitoring, and medical writing
• Biometrics – Sample size estimation, drug repackaging, database creation and management, ICH-GCP compliance, and much more
• Quality Assurance – Internal and external quality assurance activities
• Others – Survey/feasibility research, training, CRA and CRC outsourcing, and consultation